Kornimate/medical-research-clean huggingface dataset:
conjunctival allergen challenge (cac) following allergen exposure in the allergen biocube (abc)

Conditions: Allergic Rhinoconjunctivitis

Summary: to evaluate the effect of conjunctival allergen challenge (cac) with dust mites on nasal and ocular allergic symptoms following allergen exposure in the allergen biocube (abc).


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * if female, cannot be pregnant or nursing; * have a history of ocular and nasal allergy; * have a positive skin test reaction to ragweed within the past 24 months; * may/may not have a positive skin test reaction to dust mites within the past 24 months exclusion criteria: * have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the national heart, blood and lung institute classification; * have a compromised lung function; * have any ocular condition that could affect the subject's health or the study parameters; * have any presence of active ocular or sinus infection; * have significant nasal conditions; * have any significant illness that could be expected to interfere with the subject's health or with the study parameters; * use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period; * have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;

Keywords: allergic rhinitis allergic conjunctivitis
local treatment in er-positive/her2-negative oligo-metastatic breast cancer

Conditions: Breast Cancer; Recurrent Breast Cancer; Stereotactic Body Radiotherapy; Estrogen Receptor Positive Tumor; Her2-negative Tumor; Surgery

Summary: local treatment in addition to endocrine treatment as 1st line for oligo-metastatic er-positive/her2-negative breast cancer.

local treatment included surgical resection, stereotactic body radiotherapy, palliative radiotherapy, and radiofrequency ablation. stereotactic body radiotherapy is preferred as a radiation modality. endocrine therapies with/without target therapy including cdk4/6 inhibitors or mtor inhibitors are the mainstay of 1st line treatment for er-positive/her2-negative metastatic breast cancer.

Eligibility criteria:
inclusion criteria: -er-positive/her2-negative in primary tumor * oligometastases: ≤ 2 lesions in single organ or site (lung, bone, liver, adrenal glands, distant lns) * recurrent cancer after completion of primary treatment (rfi≥1year) * metastatic lesions are feasible for resection or radiotherapy (size≤3cm) exclusion criteria: * de novo metastatic cancer at initial diganosis * recurrence-free inverval \< 1 year

Keywords: oligometastasis local treatments
the analysis of gene variants related to pocd in elderly patients

Conditions: Cognitive Dysfunction

Summary: the pathophysiology of postoperative cognitive dysfunction (pocd) following surgery may be related to alzheimer's disease. different studies show that; low levels of glial cell line-derived growth factor are found in both pocd and alzheimer, and brain cholinergic markers like choline acetyl transferase activity, high affinity choline uptake activity, and acetil choline (ach) activity are decreased in alzheimer disease.we know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing. cholinergic neuron located basal section of forebrain degenerate extensively in alzheimer disease which shares similarities with postoperative delirium and pocd. ach binds to two well-known receptors in brain that are nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and pocd. dysfunction of cholinergic system may be one key aspect of postoperative delirium, pocd and alzheimer disease. in this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (preoperative and postoperative blood samples for each patient) which are apoe, phosphatidylinositol-binding clathrin assembly protein, cr1 - complement receptor 1, atp-binding cassette transporter, il6, trem.


Eligibility criteria:
inclusion criteria: * patients over age of 60 years * patients scheduled for major urologic surgery exclusion criteria: * failure of the patient or the person with legal authority to make a decision about him/her. * patients with severe hearing-vision problems before surgery. * patients with severe neurological-psychiatric disorders before surgery. * patients who cannot find a common language. * emergency surgeries
evaluate safety and efficacy of duloxetine in predominant stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: the purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.


Eligibility criteria:
inclusion criteria: * female diagnosed with stress urinary incontinence exclusion criteria: * currently taking a monoamine oxidase inhibitor
use of tinzaparin for anticoagulation in hemodialysis

Conditions: Kidney Failure, Chronic

Summary: the hemo-tin trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * end stage renal disease maintained on outpatient hemodialysis for \>= 3 months * frequency of hemodialysis: 3 times per week * anticoagulation with an unfractionated heparin protocol for at least 4 weeks * patient or legal guardian able to provide written consent * baseline inr \<= 1.3 * baseline platelet count \>= 80,000 x 10\^9/l exclusion criteria: * therapeutic systemic anticoagulation * clinically apparent bleeding in the last 2 months * high risk of bleeding * planned major surgery in the next 4 months * major surgery in the past 48 hours * pregnant or lactating * child bearing potential * allergy/intolerance to heparin or history of heparin induced thrombocytopenia * current participation in a related randomized drug trial

Keywords: hemodialysis anticoagulation tinzaparin unfractionated heparin randomized controlled trial
the informed genetics annotated patient registry

Conditions: Predisposition, Genetic

Summary: this prospective and retrospective registry will evaluate the clinical effectiveness of germline genetic, genomic, and other biomarker testing results over time in different clinical populations, in order to shape guidelines for testing, patient management, and precision therapy.

interest and knowledge about the genetics and biology of an individual's inherited risk of disease and progression of disease is growing. physicians are increasing using tests and technology, including germline genetic, genomic, and biomarker testing, to provide insight into a healthy individual's risk and an affected individual's disease characteristics, in order to provide individualized clinical treatments. however, many barriers to widespread and appropriate germline genetic, genomic, and biomarker testing persist due to complex guidelines for use, varied quality and cost, rapid advances, and adequate understanding of appropriate implementation by medical professionals. the igap registry is a multi-center ongoing database designed to capture information on disease risk assessment, germline genetic, genomic, and biomarker testing, and their utilization and impact on treatment practices and outcomes to help determine, over time, the most effective use of testing in varied patient populations and to support the increased use of precision medicine.

Eligibility criteria:
inclusion criteria for retrospective subjects: * men and women 18 years or older; * is or was a patient of a participating practice and was previously tested with germline, genomic, or other biomarker tests; and * for germline genetic test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (p/lp) result. inclusion criteria for prospective subjects: * men and women aged 18 years or older; * presents consecutively to a participating practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a participating practice or is an existing patient who returns to a participating practice); * receives or has received germline, genomic, or other biomarker testing, either through a prior healthcare provider or a participating practice; and * consents to be a part of the registry.
a study of mbs314 in participants with relapsed/refractory multiple myeloma.

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this is a phase i/ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics(pd) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, mbs314, administered by intravenous (iv) infusion in participants with relapsed or refractory multiple myeloma. this entry-to-human study is divided in 2 parts: a dose escalation part (phase ⅰa) and an expansion part (phase ⅰb/ⅱ).


Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent and to comply with the study protocol; 2. ≥18 years of age; 3. documented diagnosis of multiple myeloma according to 2014 imwg diagnostic criteria. 4. phase ⅰb/ⅱ: at least one measurable disease: serum monoclonal paraprotein (m-protein) ≥5 g/l or urine m-protein ≥200 mg/24 hours or serum immunoglobulin free-light chains (flcs) ≥100 mg/l and abnormal kappa/lambda flc ratio (\ 1.65) 5. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 6. life expectancy ≥3 months. 7. adequate hematologic, hepatic, and renal function. exclusion criteria: 1. known active central nervous system (cns) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 2. participants with known active infection within 14 days prior to the first mbs314. 3. infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c (including hbsag, hbcab positive with abnormal hepatitis b virus dna or hepatitis c virus rna). 4. previously received anti-myeloma treatment within the specified time frame prior to the first administration. 5. live, attenuated vaccines within 28 days prior to the first infusion of mbs314, or expected to receive live, attenuated vaccines during the study period. 6. major surgery within 28 days prior to the first infusion of mbs314, or expected to undergo major surgery during the study treatment. 7. participants with a history of autoimmune diseases. 8. known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of mbs314.
a systemic screening for tb disease in high-risk groups in barcelona

Conditions: Tuberculosis; Tuberculosis, Pulmonary

Summary: the purpose of this screening study is to identify and screen vulnerable population in barcelona for active pulmonary tuberculosis

if eligible and verbal consent is obtained, individuals: 1. will attend a small talk/lecture about tuberculosis (tb) disease 2. will be interviewed and screened for the presence of tb symptoms: cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks 3. individuals screened positive for tb will be referred to the hospital for further testing (chest x-ray, visit, lab tests)

Eligibility criteria:
inclusion criteria: -belonging to a population at high risk for tuberculosis (tb) exclusion criteria: -not belonging to a population at high risk for tuberculosis (tb)

Keywords: tuberculosis tuberculosis infection tuberculosis screening vulnerable populations refugees migrants pulmonary tuberculosis
novottf-200a device in treating patients with newly diagnosed high risk oligodendroglioma

Conditions: Anaplastic Oligodendroglioma; Oligoastrocytoma; Oligodendroglioma

Summary: this pilot clinical trial studies the side effects of novottf-200a device in treating patients with newly diagnosed high risk oligodendroglioma. novottf-200a device is a portable battery operated device which produces tumor treating (tt)fields in the body by means of surface electrodes placed on the skin. ttfields are very low intensity, intermediate frequency electric fields that may slow the growth of tumor cells in patients with high risk oligodendroglioma.

primary objectives: i. to describe the safety and tolerability of the ttfields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment. secondary objectives: i. to estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24. ii. to estimate the progression free survival time. iii. to assess quality of life. iv. to assess whether or not there is a correlation between genomics and the efficacy of the ttfields treatment. outline: beginning 4-8 weeks after standard of care treatment, patients wear novottf-200a device over 18 hours daily (qd). treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 2 months and then monthly thereafter.

Eligibility criteria:
inclusion criteria: * newly diagnosed oligodendroglioma (oligo) (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification * surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (soc) radiation * historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification * 1p and 19q deletion status known * idh 1 \& 2 mutations status known * mgmt status known * karnofsky equal or greater than 70 * life expectancy at least 3 months * participants of childbearing age must use effective contraception * a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * ability to understand and the willingness to sign a written informed consent exclusion criteria: * actively participating in another clinical treatment trial * tumor progression after radiation * pregnant * has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain * documented clinically significant cardiac arrhythmias * infra-tentorial tumor
a pilot randomized trial of a comprehensive transitional care program for colorectal cancer patients

Conditions: Colorectal Cancer; Comprehensive Transitional Care Program

Summary: the primary hypothesis is that a comprehensive transitional care program based on the premise of a patient-centered medical home versus routine care reduces emergency room visits and hospital readmissions without increasing costs among cancer patients undergoing surgery at a large safety-net hospital.


Eligibility criteria:
inclusion criteria: * diagnosis of colorectal cancer * adults, age 18 years or older * undergoing surgery for either palliative cure or palliation exclusion criteria: * patients not expected to survive hospital based on the operating surgeon's opinion * children under the age of 18 years
ultrasound-guided ilioinguinal/iliohypogastric nerve block compared to the combined therapy with spermatic cord block

Conditions: Hernia, Inguinal

Summary: this is a single center randomized, controlled, double-blinded, noninferiority study. male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. patients will be randomly allocated to iinb and iinb/scb groups with allocation ratio 1:1. the primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. the secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (map), the postoperative pain flacc pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.

inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block . ultrasound-guided ilioinguinal/iliohypogastric nerve block (iinb) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair . however iinb don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. the spermatic cord (sc) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (gfn). to provide complete analgesia for inguinal hernia surgery, gfn should be blocked in addition to iinb .

Eligibility criteria:
inclusion criteria: * male pediatric patients * underwent elective open unilateral inguinal herniotomy * informed written consent will be obtained from the parents or the legal guardian. exclusion criteria: * local infection at the puncture site, * bleeding disorder, * allergy to amide local anesthetics, * history of clinically significant cardiac, hepatic, or renal disorders. * neurological dysfunction

Keywords: inguinal herniotomy ilioinguinal nerve block iliohypogastric nerve block spermatic cord block
identification of neuromotor signs in preschool children suspected of developmental coordination disorder

Conditions: Motor Skills Disorders; Child Development; Child, Preschool

Summary: this prospective study aimed to detect neuromotor signs early in preschool children suspected of developmental coordination disorder (dcd). preschool children aged 3-5 years old from municipal kindergartens in thessaloniki participated in this study. the little dcdq questionnaire and the bot-2 (bruininks-oseretsky test of motor proficiency) were used for assessment.


Eligibility criteria:
inclusion criteria: * preschool children * aging from 3 to 5 years old exclusion criteria: * diagnosis for medical conditions or mental retardation

Keywords: developmental coordination disorder (dcd) little developmental coordination disorder questionnaire (little dcdq) bruininks-oseretsky test of motor proficiency (bot-2) preschool children
pilot study using a heat pack to treat cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: current standard therapies with chemotherapy (ct) for cutaneous leishmaniasis (cl) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. thermotherapy is a clinically validated first line alternative for the treatment of cutaneous leishmaniasis in south america. however, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. the investigators have adapted a reliable, safe, and low-cost heat pack for cutaneous leishmaniasis that the investigators have named the hect-cl device. in this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. the hypothesis states that the hect-cl device demonstrates efficacy non-statistically inferior to estimates for current south american pentavalent antimonial cure rates (76%) while demonstrating basic safety and tolerability.


Eligibility criteria:
inclusion criteria: * with cl diagnosed by skin smear (who method), biopsy, culture, pcr * aged 8-80 years old * with no more than 3 lesions * ulcerative and non-ulcerative ulcers less than 4 cm diameter. * allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia) * capable of signing an informed consent or having capable guardians (in the case of minors). * children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians. exclusion criteria: * lesions less than 2cm from the nose, mouth, ears, or eyes. * clinically diagnosed with mucosal involvement. * evidence of lymph node involvement on exam. * unable or unwilling to commit to the treatment and follow-up plan. * prior cl treatment within last 1 month. * pregnant or lactating * uncontrolled severe systemic illness or immunocompromised state.
provis (prolift+m and vita sexualis) study

Conditions: Pelvic Organ Prolapse

Summary: transvaginal meshes (tvm) are indicated for the treatment of pelvic organ prolapse (pop) where surgical intervention is necessary. due to a potential risk of de novo dyspareunia, tvm are mainly used in postmenopausal women and in case of recurrent pop. prolift+m (trademark) is based on a highly flexible material which is partially absorbable. we suggest that prolift+m has less impact on the vita sexualis than conventional tvm and could also be used for the treatment of younger and/or sexually active women. this study observes women who are routinely treated with prolift+m with regard to their sexual function before and after the surgery. the hypothesis is that there is no worsening in vita sexualis with prolift+m.


Eligibility criteria:
inclusion criteria: * the patient understands the nature and content of the trial * pop ≥ stage ii (according to the pop-q system (18)) * sexual intercourse ≥ 2x/4 weeks * written informed consent * negative pregnancy test in women of childbearing potential * women ≥ 18 years exclusion criteria: * concomitant surgery at the inner genitalis (e.g. colporrhaphy, sacrocolpopexy, sacrospinous fixation, hysterectomy); concomitant suburethral slings and bulking agents are allowed * unable to read or speak german * women \< 18 years * women who are pregnant or breastfeeding or planning future pregnancies * acute infection(s), e.g. untreated urogenital infections

Keywords: pelvic organ prolapse prolift+m vita sexualis
open label safety study of enteric-coated spheroid suspension in infants aged less than 12 months with presumed gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. only patients who successfully completed the 3001b3-331 study (nct00362609) or 3001b3-333 study (nct00259012) are eligible to participate in this study.


Eligibility criteria:
inclusion criteria: * successful completion of the 3001b3-331 study (nct00362609) or 3001b3-333 study (nct00259012) study. exclusion criteria: * patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Keywords: safety